WO2021009836A1

WO2021009836A1 - Endoscopic treatment tool and method for using same

Info

Publication number: WO2021009836A1
Application number: PCT/JP2019/027895
Authority: WO
Inventors: 圭紀森田; 梶　国英; 伸子松尾; 拓也奥村
Original assignee: オリンパス株式会社; 国立大学法人神戸大学
Priority date: 2019-07-16
Filing date: 2019-07-16
Publication date: 2021-01-21
Also published as: CN114096201B; US20220133290A1; CN114096201A

Abstract

The purpose of the present invention is to provide an endoscopic treatment tool that, even in a case such as where an opening is large, can deform the shape of peripheral tissue in order to make the opening easier to close. In the present invention, a tissue retraction tool (1) is provided with: a first needle (21) connected to the distal end of a first thread (22); a second needle (26) connected to the distal end of a second thread (27); a long, thin body (10) that is connected to the first thread (22) and that extends between the first thread (22) and the second thread (27); and a tube (30) disposed at the base end of the body. The tube (30) and the second thread (27) can move relatively to one another in the longitudinal direction of the tube.

Description

Endoscopic treatment tools and how to use them

The present invention relates to an endoscopic treatment tool. It also mentions how to use this endoscopic treatment tool.

There is a technique to remove a part of the stomach wall using an endoscope and a treatment tool that has been passed through the endoscope. Endoscopic submucosal dissection (ESD) removes a relatively large area of the mucosal layer and a portion of the submucosal layer, resulting in a tissue-deficient area. In endoscopic full-thickness resection (EFTR), a relatively large area of the stomach wall is resected over the entire layer, creating an opening in the stomach wall.

In order to complete the procedure, it is necessary to close the tissue defect area including the opening (hereinafter referred to as “opening”) with a suture. Closing is performed by hanging a thread on two places of the surrounding tissue sandwiching the opening and pulling the thread to bring the two places where the thread is hung close to each other. When the area of the opening is large, the distance between the two places becomes large, and the amount of movement of the needle for hanging the thread also becomes large. If the opening is large, it is necessary to hang the thread in more places. For this reason, it is not easy to close the opening with a treatment tool protruding from the endoscope.
As a method of closing the opening, a method of using a plurality of clips as described in Patent Document 1 is also known.

Japanese Patent No. 4805293

Even when the opening is closed with the clip described in Patent Document 1, it is necessary to hang the arm at two places of the surrounding tissue sandwiching the opening. However, the arm is slippery with respect to the tissue, and a reaction force is also generated when pulling the tissue, so that it takes the same or more effort to close the opening as when threading.

Based on the above circumstances, an object of the present invention is to provide an endoscopic treatment tool capable of deforming the shape of surrounding tissues in order to facilitate closing of the opening even when the opening is large or the like.

A first aspect of the present invention is a first needle connected to the distal end of the first thread, a second needle connected to the distal end of the second thread, and connected to the first thread. A tissue traction device including an elongated body extending between a first thread and a second thread and a tube arranged on the proximal end side of the body. In this tissue traction device, the tube and the second thread are configured to be relatively movable in the longitudinal direction of the tube.

The other tissue traction device of the present invention has an elongated main body connected to the first thread, the second thread, and the first thread and extending between the first thread and the second thread, and a base end side of the main body. Provided with a tube placed in. The first and second threads have ring-shaped portions. The tube and the second thread are configured to be relatively movable in the longitudinal direction of the tube.

A second aspect of the present invention is a treatment method using the tissue traction device of the present invention.
In this procedure, the first thread is fixed to the first fixation point of the luminal organ, the second thread is fixed to the second fixation point of the luminal organ, and the second fixation point is separated from the first fixation point. The tissue between the first and second fixation points is removed to form an opening.
Further, the tube and the second thread are relatively moved to increase the distance between the first fixing point and the second fixing point. As a result, the opening is elongated and the surrounding tissue of the opening is brought close to the opening, and the surrounding tissue is treated to close the opening.

According to the present invention, even if the opening is large, the shape of the surrounding tissue can be deformed in order to make it easy to close the opening, and the opening can be easily closed endoscopically.

It is an overall view of the tissue traction device which concerns on 1st Embodiment of this invention. It is a figure which shows the tissue traction device and an endoscope at the time of introduction into the body. It is a figure which shows one process of the full-thickness excision of the digestive tract using the same tissue traction device. It is a figure which shows one process of the full-thickness excision of the digestive tract using the same tissue traction device. It is a figure which shows one process of the full-thickness excision of the digestive tract using the same tissue traction device. It is a figure which shows one process of the full-thickness excision of the digestive tract using the same tissue traction device. It is a figure which shows an example of the angle adjustment operation between a tissue to be sutured and an endoscope. It is a figure which shows the main body and the sheath which concerns on the modification of the tissue traction device. It is a figure which shows the modification of the tissue traction device. It is an overall view of the tissue traction device which concerns on the 2nd Embodiment of this invention. It is a figure which shows one form at the time of using the tissue traction device. It is a figure which shows the modification of the tissue traction device. It is a figure which shows the tissue traction device which concerns on the modification of 1st Embodiment. It is a figure which shows the state which the fixed element is locked to the tissue. It is a figure which shows one process of the operation which holds the 2nd curved shape easily. It is a figure which shows one process of the operation which holds the 2nd curved shape easily. It is a figure which shows the tissue traction device which concerns on the modification of the 2nd Embodiment.

The first embodiment of the present invention will be described with reference to FIGS. 1 to 9.
FIG. 1 is an overall view of the tissue traction device 1 of the present embodiment. The tissue traction device 1 includes an elongated main body 10, two fixing elements of a first fixing element 20 and a second fixing element 25 provided at both ends of the main body 10, and a sheath provided on the base end side of the main body 10. (Tube) 30 is an endoscopic treatment tool.

The main body 10 is made of resin, metal, or the like and is formed in an elongated shape such as a rod shape, a strip shape, or a tubular shape. The main body 10 has a tip portion 11, a base end portion 12, and an intermediate portion 13 between the tip end portion 11 and the base end portion 12. The intermediate portion 13 is curved in an arc shape (first curved shape) in a natural state where no external force acts. The main body 10 has flexibility.

The first fixing element 20 has a first needle 21 and a first thread 22. The first needle 21 is a curved needle, the first needle 21 is connected to the distal end of the first thread 22, and the proximal end of the first thread 22 is connected to the main body 10.
The second fixing element 25 has a second needle 26 and a second thread 27. The second needle 26 is also a curved needle, the second needle 26 is connected to the distal end of the second thread 27, and the proximal end of the second thread 27 is shown enlarged in the hole 12a of the main body 10. The main body 10 and the second thread 27 are connected to each other by being inserted into the inside (). The body 10 extends between the proximal end of the first thread 22 and the proximal end of the second thread 27. The second thread 27 protruding from the sheath 30 can slide in the hole 12a between the second needle 26 and the tip of the sheath 30.

The sheath 30 is a flexible tubular member and has lumens extending along a longitudinal axis. The second thread 27 can advance and retreat with respect to the sheath 30. As shown in FIG. 1, the second thread 27 is preferably arranged so as to enter the sheath 30 through the tip opening 31 of the sheath 30 and exit from the proximal opening 32 through the lumen (hole) of the sheath 30. Further, instead of the lumen, a guide hole through which the second thread 27 passes may be formed only at the tip end portion of the sheath 30. In this case, the second thread 27 may be passed through the guide hole, and the second thread 27 coming out of the guide hole may be arranged to come out of the forceps plug via the channel of the endoscope.

The operation when the tissue traction device 1 of the present embodiment configured as described above is used will be described. In the following description, an example will be taken in which a part of the wall of a luminal organ such as the stomach is completely resected by EFTR.

First, the user introduces the tissue traction device 1 together with the endoscope into the body to be treated.
FIG. 2 shows an example of the endoscope 100 and the tissue traction device 1 at the time of introduction into the body. The endoscope 100 and the tissue traction device 1 are introduced into the body through the mouth or the like while the main body 10 is placed along the insertion portion 101 of the endoscope while the two fixing elements are grasped by the forceps 110 or the like inserted into the endoscope. Will be done. In FIG. 2, the sheath 30 (not shown) is removed from the second thread 27, but the sheath 30 may be introduced into the body together with the second thread 27 while passing through the sheath 30.

In FIG. 2, the forceps 110 grip the first thread 22 and the second thread 27, but the first needle 21 and the second needle 26 may be gripped. A cap may be attached to the tip of the endoscope 100, and the first needle 21 and the second needle 26 may be positioned in the cap and introduced into the body.

The user confirms the region R to be excised with the endoscope 100, and determines the positions of two fixing points for fixing the fixing element in the tissue ST surrounding the region R. If fixed points are set one by one at positions sandwiching the region R in the advancing / retreating direction of the endoscope 100, the procedure of closing the opening after that can be easily performed. The distance between the two fixing points is set shorter than the distance between the tip end portion 11 and the base end portion 12 in the main body 10.

Next, the user hangs the first needle 21 on the back side (position farther from the endoscope 100) fixed point F1 (first fixed point) with forceps such as a needle holder protruding from the endoscope. The first thread 22 is locked to the fixed portion F1. Further, the second needle 26 is hung on the other fixing point F2 (second fixing point) using forceps, and the second thread 27 is locked to the fixing point F2.
This completes the attachment of the tissue traction device 1 to the gastrointestinal wall as shown in FIG. Either the fixing of the fixing element to the fixing portion F1 or the fixing of the fixing element to the fixing portion F2 may be performed first. In the case of EFTR, if a part of the gastrointestinal tract is excised and an opening (described later) is made, the gastrointestinal tract is deflated and it becomes difficult to fix it. Locking with the two threads 27) is preferably performed before full-thickness excision.

Next, as shown in FIG. 4, the user performs full-thickness excision of the region R using a high-frequency knife 120 or the like. Since the main body 10 is arcuate in the natural state and the base end portion 12 is not yet fixed to the fixed portion F2, even if the fixing element on the tip side is fixed to the fixed portion F1, it is difficult to straddle the region R, and the whole body 10 is It does not interfere with the layer excision procedure. In addition, it can be easily evacuated even when straddling the area R.
By full-thickness excision, an opening Op is formed in the region R. When the target procedure is ESD, a bottomed opening is formed in the region R where the mucosal layer is excised together with a part of the submucosal layer.

After the full-thickness excision is completed, the user passes the end of the second thread 27 outside the body through the sheath 30 and introduces the sheath 30 into the body along the second thread 27. If the sheath 30 becomes difficult to move due to interference with the gastrointestinal wall on the way, the endoscope 100 is once retracted to check the condition of the interference site, and the sheath 30 is used with an endoscope, a treatment tool, or the like. May be assisted in the introduction of.

When the tip of the sheath 30 reaches the vicinity of the main body 10, the user brings the tip of the sheath 30 into contact with the base end portion 12 of the main body 10 while looking at the main body 10 with the endoscope 100.
The user moves the second thread 27 and the sheath 30 relative to each other to retract the second thread 27 with respect to the sheath 30. Then, the tip portion 11 of the main body 10 pushed by the sheath 30 moves forward. Along with this, the tissue (fixed portion F1) locked to the first thread 22 connected to the tip portion 11 moves to the distal side. Since the second thread 27 is locked to the fixed portion F2, the movement of the fixed portion F1 is not completely followed, and the distance between the fixed portion F1 and the fixed portion F2 gradually increases.
As a result, as shown in FIG. 5, the opening Op is elongated and deformed in the extending direction of the line connecting the fixed portion F2 and the fixed portion F1. As a result, the surrounding tissues ST of the opening Op also approach each other. By holding a part (operating portion) of the sheath 30 and the second thread 27 located outside the body, the user can keep the opening Op in a stretched state.
Basically, it is desirable that the main body 10 has a rigidity that hardly changes even when the sheath 30 is pressed. When the main body 10 is pushed by the sheath 30, the same effect can be exhibited even if the intermediate portion 13 of the main body 10 is deformed into a second curved shape having a radius of curvature slightly smaller than that of the first curved shape.
There is no particular limitation on the mode in which the second thread 27 and the sheath 30 are relatively moved. For example, the second thread 27 may be pulled while holding the sheath 30, or the sheath 30 may be pushed in while holding the second thread 27. Alternatively, the second thread 27 may be pulled while pushing the sheath 30. If the base end portion 12 cannot be sufficiently pressed by the sheath 30, the pressing force may be added by pressing the endoscope 100 or grasping the sheath with forceps protruding from the endoscope. As another example, a forceps or the like having a gripping function may be provided at the tip of the sheath 30, and the main body 10 may be directly gripped by the forceps or the like to push the main body 10.

As shown in FIG. 6, the user sutures and closes the opening Op using a needle 131 and a thread 132 separately introduced into the body while maintaining the stretched state of the opening Op. Since the opening Op is stretched, the surrounding tissue ST sandwiching the opening Op is close to each other, so that the needle can be hooked on the surrounding tissue ST of the opening Op with a small amount of movement of the needle, which is easier than before. Can be sutured.
Instead of the needle 131 and the thread 132, other medical devices such as clips and staplers may be used to close the opening Op.

As shown in FIG. 7, when the second thread 27 and the sheath 30 are pulled while maintaining the positional relationship, the fixed portion F2 can be pulled toward the mouth side. This operation is useful for adjusting the angle θ formed by the tangential direction of the tissue of the tube wall to be closed and the longitudinal axis of the forceps protruding from the endoscope 100.

After closing the opening Op by suturing, the user cuts the first thread 22 and the second thread 27 to separate the tissue traction device 1 from the gastrointestinal tract, and finally tissue traction including the first needle 21 and the second needle 26. The entire instrument 1 is removed from the body together with the endoscope 100 to complete a series of procedures.
The first needle 21 and the second needle 26 may be recovered immediately after the attachment of the tissue traction device 1 to the gastrointestinal wall is completed.

As described above, in the tissue traction device 1 of the present embodiment, the first fixing element 20 and the second fixing element 25 provided at both ends of the main body 10 are fixed to two fixing points around the region to be excised. Then, by relatively moving the sheath 30 and the second thread 27 in a predetermined direction, the region after opening or excision can be elongated and the tissues around the region can be brought close to each other. As a result, the procedure for closing the opening can be performed more easily than before.

In the present embodiment, the mode of the fixing element is not limited to the needle and thread described above, and various structures can be used. In the modified example shown in FIG. 13, the fixing elements are

rings

71 and 72. The ring 71 is formed by forming the first thread 22A into a ring shape and connecting both ends to the tip portion 11 of the main body 10. The ring 72 is formed by forming a part of the second thread 27A into a ring shape. The second thread 27 is inserted through the sheath 30, and the second thread 27 including the ring 72 protrudes from the tip of the sheath 30. The second thread 27 protruding from the sheath 30 is inserted between the ring 72 and the tip of the sheath 30 into a hole 12a formed in the base end portion of the main body 10 so as to be freely reciprocated.
When the ring 71 is positioned on the tissue, one arm 76 of the endoscopic clip 75 is positioned in the ring 71 and the tissue is ligated with the clip 75 as shown in FIG. 14, the ring 71 can be locked to the tissue. .. Similarly, the ring 72 can also be locked to the tissue by ligating the tissue with a clip 75 or the like. The material of the

rings

71 and 72 is not limited to the first thread and the second thread, but if the

rings

71 and 72 are formed of a material that can be easily cut such as a thread, the tissue traction device after use can be easily separated from the tissue. ..

In the present embodiment, as shown in FIG. 8, the main body 10 and the sheath 30 may be connected. In the modified example having such a configuration, it is not necessary to pass the second thread 27 through the main body 10. Further, it is not necessary to bring the tip of the sheath 30 into contact with the base end portion 12 of the main body 10 when extending the opening, and the operation of moving the main body 10 forward is stable.
The material of the main body 10 and the material of the sheath 30 may be the same or different.

The tissue traction device 1A of the modified example shown in FIG. 9 has a configuration in which a traction lead 40 is connected to a second thread 27. The lead 40 is an elongated member, and for example, a wire or a thread is preferable. In this modification, the second thread 27 is short, and the second thread 27 and the lead 40 are connected at a knot 28. The lead 40 is passed through the hole 12a of the main body 12, and the knot 28 is sized so that it cannot pass through the hole 12a.
In the tissue traction device 1A, the second thread 27 and the main body 10 are not connected, but the opening can be elongated by almost the same operation as the tissue traction device 1. Further, when the base end portion of the main body 10 comes into contact with the knot 28, it does not move any further, so that the main body is prevented from being pressed against the tissue more than necessary.

The second embodiment of the present invention will be described with reference to FIGS. 10 and 11. In the following description, the same reference numerals will be given to the configurations common to those already described, and duplicate description will be omitted.

FIG. 10 shows the tissue traction device 51 according to the present embodiment. The tissue traction device 51 includes a tubular main body 52 instead of the main body 10 of the first embodiment. The main body 52 has a substantially linear shape. The first thread 22 is connected to the main body 52 by passing through the main body 52. The first thread 22 is inserted into the sheath 30 from the base end portion 53 of the main body 52.
The second thread 27 is not connected to the main body 52 but is passed through the sheath 30.
Other configurations are the same as those of the tissue traction device 1 of the first embodiment.

Similarly to the first embodiment, the tissue traction device 51 of the present embodiment can also extend the opening in an elongated manner by relatively moving the second thread 27 and the sheath 30, and bring the tissues around the region close to each other.

In the tissue traction device 51, the first thread 22 is passed through the tubular main body 52. Therefore, when the sheath 30 is retracted and the main body 52 is pulled toward the hand side with forceps or the like, the tip portion of the main body 52 can be moved along the first thread 22 in a direction away from the fixed portion F1 as shown in FIG. .. Therefore, even if the main body is substantially linear, it is possible to sufficiently suppress the main body 52 from interfering with the high frequency knife 120 or the like when performing full-thickness cutting or the like.

In the present embodiment, the first thread does not have to be passed through the main body 52. In the tissue traction device 61 of the modified example shown in FIG. 12, the evacuation thread 63 is connected to the first thread 22 at the portion of the knot 62, and the evacuation thread 63 passes through the main body 52 and is passed through the sheath 30.
Even with such a configuration, the main body 52 can be moved along the evacuation thread 63 to suppress interference between the main body and a high-frequency knife or the like.

Although each embodiment of the present invention has been described above, the technical scope of the present invention is not limited to the above-described embodiment, and the combination of components may be changed or each component may be changed without departing from the spirit of the present invention. It is possible to make various changes to and delete.
Some changes are illustrated below, but not all, but other changes are possible. These changes may be combined as appropriate.

-In the second embodiment, the mode of the fixing element is not limited to the needle and thread described above, and various structures can be used. In the modified example shown in FIG. 17, the fixing elements are

rings

71B and 72B. The ring 71B and the ring 72B are formed by forming a part of the first thread 22B and the second thread 27B into a ring shape, respectively.
The first thread 22B is inserted into the sheath 30 freely, and the first thread 22B protruding from the tip of the sheath 30 is between the ring 71B of the first thread 22B and the tip of the sheath 30 and the main body 52. It is inserted freely in and out. The second thread 27B including the ring 72B protrudes from the tip of the sheath 30. Then, the

rings

71B and 72B can be locked to the tissue by ligating the tissue with a clip 75 or the like, as in the modified examples shown in FIGS. 13 and 14.

As shown in FIG. 15, the indwelling snare 130 is hung on the sheath 30 in advance, and as shown in FIG. 16, the second thread 27 between the main body 10 and the sheath 30 in a state where the opening Op is stretched is placed in the indwelling snare. You may tie it with 130. In this way, even if the sheath 30 is released from the sheath or the sheath 30 is removed from the body, the open opening Op can be maintained in a stretched state, which simplifies the operation of the user. Even if the lead 40 is sandwiched by a clip or the like instead of the indwelling snare, the state in which the opening Op is stretched can be maintained. The positional relationship between the sheath 30 and the second thread 27 may be fixed by fixing the second thread 27 to the operating portion. In this case, even if the user releases the sheath 30 without removing the sheath 30, the open opening Op can be maintained in the stretched state.

The present invention can be applied to tissue traction devices and endoscopic procedures.

1, 1A, 51, 61

Tissue traction device

10, 10A, 52 Body 11

Tip

12, 53 Base 21 First needle 22 First thread 26 Second needle 27 Second thread 30 Sheath (tube)
F1 (1st) Fixed place F2 (2nd) Fixed place Op Aperture ST Surrounding tissue

Claims

With the first needle connected to the distal end of the first thread,
With the second needle connected to the distal end of the second thread,
An elongated body that is connected to the first thread and extends between the first thread and the second thread,
The tube arranged on the base end side of the main body and
With
The tube and the second thread are configured to be relatively movable in the longitudinal direction of the tube.
Tissue traction device.
The body is connected to the proximal end of the first yarn and extends between the proximal end of the first yarn and the proximal end of the second yarn.
The tissue traction device according to claim 1.
A part of the second thread is inserted into the tube from the tip end portion of the tube and protrudes from the base end portion of the tube.
The tissue traction device according to claim 1.
The main body is curved in an arc shape,
The tissue traction device according to claim 1.
The main body has a hole, and the second thread is inserted into the hole so as to be able to advance and retreat at a position between the second needle and the tip of the tube.
The tissue traction device according to claim 1.
The tube has a hole, and the second thread is inserted into the hole so as to be able to advance and retreat.
The tissue traction device according to claim 1.
First thread and
With the second thread
An elongated body that is connected to the first thread and extends between the first thread and the second thread,
The tube arranged on the base end side of the main body and
With
The first thread and the second thread have a ring-shaped portion and have a ring-shaped portion.
The ring-shaped portion of the first yarn protrudes from the main body, and the ring-shaped portion of the second yarn protrudes from the tube.
The tube and the second thread are configured to be relatively movable in the longitudinal direction of the tube.
Tissue traction device.
The body is connected to the proximal end of the first yarn and extends between the proximal end of the first yarn and the proximal end of the second yarn.
The tissue traction device according to claim 7.
A part of the second thread is inserted into the tube from the tip end portion of the tube and protrudes from the base end portion of the tube.
The tissue traction device according to claim 7.
The main body is curved in an arc shape,
The tissue traction device according to claim 7.
The main body has a hole, and the second thread is inserted into the hole so as to be able to advance and retreat at a position between the ring-shaped portion of the second thread and the tip of the tube.
The tissue traction device according to claim 7.
The tube has a hole, and the second thread is inserted into the hole so as to be able to advance and retreat.
The tissue traction device according to claim 7.
The first thread is inserted into the tube so as to be able to advance and retreat.
The first thread protruding from the tip of the tube is inserted into the main body in an advancing and retreating manner between the ring-shaped portion of the first thread and the tip of the tube.
The tissue traction device according to claim 7.
A treatment method using the tissue traction device according to claim 1.
The first thread is fixed to the first fixation point of the luminal organ,
The second thread is fixed to the second fixing point of the luminal organ, and the second fixing point is separated from the first fixing point.
The tissue between the first fixing point and the second fixing point is removed to form an opening.
By relatively moving the tube and the second thread and increasing the distance between the first fixing point and the second fixing point, the opening is elongated and the tissue surrounding the opening is brought closer to each other.
Treating the surrounding tissue to close the opening,
Treatment method.
After forming the opening, the first yarn is fixed to the first fixing portion.
The treatment method according to claim 14.
After fixing the first yarn to the first fixing portion, the opening is formed.
The treatment method according to claim 14.
A treatment method using the tissue traction device according to claim 7.
The first thread is fixed to the first fixation point of the luminal organ,
The second thread is fixed to the second fixing point of the luminal organ, and the second fixing point is separated from the first fixing point.
The tissue between the first fixing point and the second fixing point is removed to form an opening.
By relatively moving the tube and the second thread and increasing the distance between the first fixing point and the second fixing point, the opening is elongated and the tissue surrounding the opening is brought closer to each other.
Treating the surrounding tissue to close the opening,
Treatment method.
After forming the opening, the first yarn is fixed to the first fixing portion.
The treatment method according to claim 17.
After fixing the first yarn to the first fixing portion, the opening is formed.
The treatment method according to claim 17.